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510(k) K810875

FECAL STAINING KIT by Jayco Pharmaceuticals — Product Code KKJ

K810875 is an FDA 510(k) premarket notification submitted by Jayco Pharmaceuticals for the device "FECAL STAINING KIT". The FDA issued a decision of Substantially Equivalent on May 1, 1981. The device falls under product code KKJ (Sudan Iii), a Class I device regulated under 21 CFR 864.1850. Jayco Pharmaceuticals has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1981
Date Received
March 31, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sudan Iii
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Jayco Pharmaceuticals

  • K844690 — ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT (January 2, 1985)
  • K844689 — ENDOSCOPIC MANUAL AIR INSUFFLATOR (January 2, 1985)
  • K844691 — ENDOSCOPIC ASPIRATION CATHETER SET (January 2, 1985)
  • K842009 — ABDOMINAL PARACENTESIS TRAY (October 23, 1984)
  • K842001 — LIVER BIOPSY TRAY (October 15, 1984)
  • K841258 — FOREIGN BODY PROTECTOR (July 9, 1984)
  • K840800 — POLYP-SAVER SLEVE (March 23, 1984)
  • K830781 — ENDO-GUARD (March 31, 1983)

FDA data resources